Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Adroit Medical Systems, Inc. · Predicate Candidate Screening

6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

196 daysmedian FDA review time
232 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K073712SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100Adroit Medical Systems, Inc.2008-06-061580
K973981SAFEPASS STERILIZATION POUCHAdroit Medical Systems, Inc.1998-01-291010
K970197HTP-1500 LOCALIZED HEAT THERAPY PUMPAdroit Medical Systems, Inc.1997-09-102320
K962983STERILE SOFT-TEMPAdroit Medical Systems, Inc.1997-01-101620
K921920SOFT-TEMPAdroit Medical Systems, Inc.1992-12-112320
K921928SOFT-COVERAdroit Medical Systems, Inc.1992-11-061960

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda